Bremnes, Frida
Øien, Cecilia Montgomery
Kvaerness, Jørn
Jaatun, Ellen Andreassen
Aas, Sigve Nyvik
Saether, Terje
Lund, Henrik
Romundstad, Solfrid
Funding for this research was provided by:
The Research Council of Norway (313922)
Stiftelsen Dam
Article History
Received: 3 August 2023
Accepted: 25 December 2024
First Online: 8 January 2025
Declarations
:
: Written informed consent was obtained from each participant prior to study enrolment. The study was approved by the Regional Committee for Medical and Health Research Ethics in Norway (REK Midt-Norge, reference 171341) and the Norwegian Medicines Agency (NoMA, reference 21/11055). The study complied with the Declaration of Helsinki and was conducted in accordance with ISO14155:2020 – Good clinical practice.
: Not applicable.
: Solfrid Romundstad and Cecilia Montgomery Øien declare no conflict of interest. Frida Bremnes, Terje Sæther, and Sigve Nyvik Aas are employed by Mode Sensors AS, the company developing the sensor tested in the clinical investigation. Jørn Kværness and Ellen Andreassen Jaatun are former employees, and Henrik Lund is a board member. Jørn Kværness, Ellen Andreassen Jaatun, and Terje Sæther have shares in the company. Sigve Nyvik Aas, Frida Bremnes, and Henrik Lund have stock options.